Dacogen 50 mg powder for concentrate for solution for infusion.

  • Name:

    Dacogen 50 mg powder for concentrate for solution for infusion.

  • Company:
    info
  • Active Ingredients:

    Decitabine

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/04/19

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Summary of Product Characteristics last updated on medicines.ie: 24/4/2019

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Janssen Sciences Ireland

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1 - 0 of 55 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 24 April 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 April 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8     Undesirable effects

 

 

System Organ Class

 

Metabolism and nutrition disorders

Very common

hyperglycaemia

13

3

 

 

5        PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

 

Dacogen‑treated subjects (11%, 24/223) experienced worsening of hyperglycaemia compared with subjects in the TC arm (6%, 13/212).

Updated on 11 February 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 8 February 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.4     Special warnings and precautions for use

 

 

Cardiac disease

Patients with a history of severe congestive heart failure or clinically unstable cardiac disease were excluded from clinical studies and therefore the safety and efficacy of Dacogen in these patients has not been established. Cases of cardiomyopathy with cardiac decompensation, in some cases reversible after treatment discontinuation, dose reduction or corrective treatment, have been reported in the postmarketing setting. Patients, especially those with cardiac disease history, should be monitored for signs and symptoms of heart failure

 

 

 

4.8     Undesirable effects

 

 

 

Cardiac disorders

Uncommon

Cardiomyopathy

< 1

< 1

 

Updated on 29 January 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 29 January 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2     Posology and method of administration

 

Paediatric population

The safety and efficacy of Dacogen in children aged < 18 years have not yet been established. No data are availableDacogen should not be used in children with AML aged < 18 years, because efficacy was not established. Currently available data are described in sections 4.8, 5.1, and 5.2.

 

4.4     Special warnings and precautions for use

 

Excipients

This medicine contains 0.5 mmol potassium per vial. After reconstitution and dilution of the solution for intravenous infusion, this medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free’.

This medicine contains 0.29 mmol (6.67 mg) sodium per vial. After reconstitution and dilution of the solution for intravenous infusion, this medicine contains between 13.8 mg‑138 mg (0.6‑6 mmol) sodium per dose (depending on the infusion fluid for dilution), equivalent to 0.7‑7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.

 

4.8     Undesirable effects

 

Paediatric population

The safety assessment in paediatric patients is based on the limited safety data from a Phase I/II study to evaluate pharmacokinetics, safety and efficacy of Dacogen in paediatric patients (aged 1 to 14 years) with relapsed or refractory AML (n = 17) (see section 5.1). No new safety signal was observed in this paediatric study.

4.2     Posology and method of administration

 

Paediatric population

The safety and efficacy of Dacogen in children aged < 18 years have not yet been established. No data are availableDacogen should not be used in children with AML aged < 18 years, because efficacy was not established. Currently available data are described in sections 4.8, 5.1, and 5.2.

 

4.4     Special warnings and precautions for use

 

Excipients

This medicine contains 0.5 mmol potassium per vial. After reconstitution and dilution of the solution for intravenous infusion, this medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free’.

This medicine contains 0.29 mmol (6.67 mg) sodium per vial. After reconstitution and dilution of the solution for intravenous infusion, this medicine contains between 13.8 mg‑138 mg (0.6‑6 mmol) sodium per dose (depending on the infusion fluid for dilution), equivalent to 0.7‑7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.

 

4.8     Undesirable effects

 

Paediatric population

The safety assessment in paediatric patients is based on the limited safety data from a Phase I/II study to evaluate pharmacokinetics, safety and efficacy of Dacogen in paediatric patients (aged 1 to 14 years) with relapsed or refractory AML (n = 17) (see section 5.1). No new safety signal was observed in this paediatric study.

Updated on 12 December 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 December 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

Hepatic impairment

Use in patients with hepatic impairment has not been established. Caution should be exercised in the administration of Dacogen to patients with hepatic impairment and patients should be monitored closely and in patients who develop signs or symptoms of hepatic impairment. Liver function tests should be performed prior to initiation of therapy and prior to each treatment cycle, and as clinically indicated (see sections 4.2 and 5.2).

 

Renal impairment

Use in patients with severe renal impairment has not been studied. Caution should be exercised in the administration of Dacogen to patients with severe renal impairment (Creatinine Clearance [CrCl] < 30 ml/min) and these patients should be monitored closely. Renal function tests should be performed prior to initiation of therapy and prior to each treatment cycle, and as clinically indicated (see section 4.2).

 

 

4.8     Undesirable effects

 

Hepatobiliary disorders

Very common

hepatic function abnormal

11

3

Common

hyperbilirubinaemiag

5

<1

 

 

Updated on 24 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Removal/change of distributor

Updated on 30 August 2017 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.6          Special precautions for disposal and other handling

 

Reconstitution procedure

The powder should be aseptically reconstituted with 10 ml of water for injections. Upon reconstitution, each ml contains approximately 5 mg of decitabine at pH 6.7 to 7.3. Within 15 minutes of reconstitution, the solution must be further diluted with cold infusion fluids (sodium chloride 9 mg/ml [0.9%] solution for injection or 5% glucose solution for injection) to a final concentration of 0.15 to 1.0 mg/ml. For the shelf-life and the precaution for storage after reconstitution, see section 6.3.

Updated on 30 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 30 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 August 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 25 May 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Removal of black triangle statement.

 

Administrative chnages to sections 4.2, 4.3, 4.5, 4.6, 4.7, 4.8,  6.5, 6.6,  9 and 10

 

2          QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each vial of powder for concentrate for solution for infusion contains 50 mg decitabine.

 

4.4       Special warnings and precautions for use

Excipients

This medicine contains 0.5 mmol potassium per vial. After reconstitution and dilution of the solution for intravenous infusion, this medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free’.between 1-10 mmol potassium per dose depending on the infusion fluid for dilution. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

 

Updated on 24 May 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Removal of black triangle

Updated on 2 March 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

.4         Special warnings and precautions for use

Respiratory, thoracic and mediastinal disorders

Cases of interstitial lung disease (ILD) (including pulmonary infiltrates, oganising pneumonia and pulmonary fibrosis) without signs of infectious aetiology have been reported in patients receiving decitabine. Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD. If ILD is confirmed, appropriate treatment should be initiated (see section 4.8).

 

4.8       Undesirable effects

 

Respiratory, thoracic and mediastinal disorders

Very common

epistaxis

14

2

Not known

interstitial lung disease

Not known

Not known

 

 

Respiratory, thoracic and mediastinal disorders

Cases of interstitial lung disease (including pulmonary infiltrates, organising pneumonia and pulmonary fibrosis) without signs of infectious aetiology have been reported in patients receiving decitabine.

 

Updated on 28 February 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 8 July 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



4.1     Therapeutic indications

 

Dacogen is indicated for the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

Updated on 6 July 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 8 April 2015 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.3 Shelf life

Reconstituted and diluted solution

Within 15 minutes of reconstitution, Tthe concentrate (in 10 ml of sterile water for injections) must be further diluted within 15 minutes using infusion fluids after reconstitution. The prepared diluted solution for intravenous infusion can be stored at room temperature (20°C - 25°C) for up to a maximum of 2 hours before administration.

 

If administration of the diluted solution for intravenous infusion is not intended to start within 2 hours, the concentrate must be diluted within 15 minutes of reconstitution using pre-cooled with cold (2°C - 8°C) infusion fluids. This prepared diluted solution for intravenous infusion mustcan be stored refrigerated at 2°C - 8°C for up to a maximum of 73 hours, and can then be stored followed by up to 1 hour at room temperature (20°C - 25°C) for up to 2 hours before administration.

 

 

From a microbiological point of view, the product should be used within the time period recommended above. It is the responsibility of the user to follow the recommended storage times and conditions and ensure that reconstitution has taken place in aseptic conditions.


6.6     Special precautions for disposal and other handling


Reconstitution procedure

The powder should be aseptically reconstituted with 10 ml of water for injections. Upon reconstitution, each ml contains approximately 5 mg of decitabine at pH 6.7 to 7.3. Immediately afterWithin 15 minutes of reconstitution, the solution shouldmust be further diluted with cold infusion fluids [sodium chloride 9 mg/ml (0.9%) solution for injection or, 5% glucose solution for injection], or Lactated Ringer’s solution for injection to a final concentration of 0.1 to 1.0 mg/ml. For the shelf-life and the precaution for storage after reconstitution, see section 6.3.


Updated on 2 April 2015 PIL

Reasons for updating

  • Change to storage instructions

Updated on 4 August 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8

IMB name changed to HPRA

Addition of enterocolitis, including neutropaenic colitis and caecitis as 'not known' ADRs

Updated on 31 July 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 23 January 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 22 January 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

Myelosuppression

Myelosuppression and complications of myelosuppression, including infections and bleeding that occur in patients with AML may be exacerbated with Dacogen treatment. Therefore patients are at increased risk for severe infections (due to any pathogen such as bacterial, fungal and viral), with potentially fatal outcome (see section 4.8). Patients should be monitored for signs and symptoms of infection and treated promptly.

 

In clinical studies, the majority of patients had baseline Grade 3/4 myelosuppression. In patients with baseline Grade 2 abnormalities, worsening of myelosuppression was seen in most patients and more frequently than in patients with baseline Grade 1 or 0 abnormalities. Myelosuppression caused by Dacogen is reversible. Complete blood and platelet counts should be performed regularly, as clinically indicated and prior to each treatment cycle. In the presence of myelosuppression or its complications, treatment with Dacogen may be interrupted and/or supportive measures instituted (see sections 4.2 and 4.8).

4.8     Undesirable effects

 

Infections and infestations

Very common

pneumonia*

24

20

urinary tract infection*

15

7

All other infections (viral, bacterial, fungal)*,b,c

63

39

Common

septic shock*

6

4

sepsis*

9

8

sinusitis

3

1

 

b     Excluding pneumonia, urinary tract infection, sepsis, septic shock and sinusitis.

c     The most frequently reported "other infections" in study DACO-016 were: oral herpes, oral candidiasis, pharyngitis, upper respiratory tract infection, cellulitis, bronchitis, nasopharyngitis.

Description of selected adverse drug reactions


Haematologic adverse drug reactions

The most commonly reported haematologic adverse drug reactions associated with Dacogen treatment included febrile neutropenia, thrombocytopenia, neutropenia, anaemia and leukopenia.

 

Serious bleeding-related adverse drug reactions, some of which lead to a fatal outcome, such as central nervous system (CNS) haemorrhage (2%) and gastrointestinal (GI) haemorrhage (2%), in the context of severe thrombocytopenia, were reported in patients receiving Dacogen.

 

Haematological adverse drug reactions should be managed by routine monitoring of complete blood counts and early administration of supportive treatments as required. Supportive treatments include, administration of prophylactic antibiotics and/or growth factor support (e.g., G-CSF) for neutropenia and transfusions for anaemia or thrombocytopenia according to institutional guidelines. For situations where decitabine administration should be delayed, see section 4.2.

 

Infections and infestations adverse drug reactions

Serious infection-related adverse drug reactions, with potentially fatal outcome, such as septic shock, sepsis, pneumonia, and other infections (viral, bacterial and fungal) were reported in patients receiving Dacogen.

 

Updated on 8 October 2013 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 7 October 2013 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

-

Updated on 1 November 2012 PIL

Reasons for updating

  • New PIL for new product

Updated on 31 October 2012 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided